MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T; BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number 500101

Device Problem Defective Alarm (1014)

Patient Problem Failure of Implant (1924)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

The syncardia certified hospital declined to return the right ventricle to syncardia for evaluation, therefore, only a review of the device history record (dhr) was performed.The dhr review revealed no anomalies and confirmed that all manufacturing was performed to specifications.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).

Event Description

The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: (1) companion 2 driver s/n (b)(4) (mfr report # 3003761017-2017-00063 and (2) 70cc tah-t l/n 107698-70cc (mfr report # 3003761017-2017-00064).The customer, a syncardia authorized distributor, reported that the companion 2 driver exhibited very low right cardiac output alarms while supporting a patient.The customer also reported that the hospital staff did not exchange the companion 2 driver for a backup driver.The customer also reported that the patient had a history of pulmonary issues and the hospital staff suspected there was a possible pulmonary embolism.The hospital staff performed imaging and decided surgery was indicated due to the image results.The doctors felt there was possible evidence of a clot inside the ventricle that could be having an effect on the temporary total artificial heart (tah-t) and therefore causing the companion 2 driver to exhibit very low right cardiac output alarms.The customer also reported that the right ventricle was removed and it was found to be clear of any clot or any other debris.The hospital staff also examined the inflow to the right ventricles (the right atrium and the connector) and they were completely clean from any clot.The hospital staff also examined the outflow vascular graft and it was also free from any clot or other obstructions.The customer also reported that the doctors replaced the right ventricle of the tah-t with a new right ventricle.

• Brand Name: SYNCARDIA 70CC TAH-T
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6552745
• MDR Text Key: 74697501
• Report Number: 3003761017-2017-00064
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008(10)107698(11)16102
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 500101
• Device Lot Number: 107698-70CC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR